1. Field of the Invention
The present invention relates to a gusseted bag for medicinal or medical purposes that can be applied to a disposable sterilized container, which is subjected to no rinsing or sterilizing treatment for reiteration use, thus permitting use without validation.
2. Description of the Related Art
There has conventionally been used a drum can or box-shaped container made of stainless steel as a container for receiving intermediate products for pharmaceuticals. The drum can or box-shaped container, which has already been used for the intended use, must be subjected to a rinsing treatment for reiteration use to clean the inside of the drum can or box-shaped container. The drum can has for example the diameter of 50 cm and the height of 2 m and the box-shaped container has for example the dimensions of 1 m.times.1 m.times.1 m. The rinsing treatment of the inside of the drum can or box-shaped container however requires a great deal of labor and much time. In addition, there may occur problems of cross contamination and validation requires a long period of time and much cost in view of such problems of the cross contamination. As a result, there may be nothing for it but to dispose of the used drum can or box-shaped container.
There is, on the other hand, a demand that waste of resources should be avoided through reiteration use of the drum can or box-shaped container made of stainless steel. In reply to such a demand, there has been proposed a technical measures of placing an inner bag formed of polyethylene film in the drum can or box-shaped container made of stainless steel so that intermediate products for pharmaceuticals can be received in the inner bag and the used inner bag can be disposed after the completion of the intended use, thus permitting reiteration use of the drum can or box-shaped container made of stainless steel.
In general, a polyethylene film contains additives such as slipping agent, stabilizer, filler and the like. However, these additives should not be contained in a film for medicinal or medical purposes in view of medicinal or medical regulation. Therefore, such a film has a relatively small strength. In addition, the inner bag formed of the above-mentioned polyethylene film, which is to be placed in the drum can or box-shaped container is manufactured by heat-sealing the bottom portion of a tubular body formed of the polyethylene film under a collapsed condition, or by heat-sealing three portions, i.e., the both side portions and the bottom portion of a pair of polyethylene films placed on each other. The thus manufactured inner bag has no gusset, and the heat-sealed bottom portion thereof cannot accordingly be brought into close contact with the inner surface and the bottom surface of the drum can or box-shaped container, thus leading to a possible occurrence of breakage of the inner bag placed in the drum can or box-shaped container due to influences with respect to medicinal processes and vibration caused by transportation.
The other inner bag formed of polypropylene has also conventionally been proposed. The other inner bag mentioned above contains the same additives as described above, and is relatively brittle and has a poor impact resistance at a low temperature.